Phase II study of S-1 in patients with advanced biliary tract cancer

British Journal of Cancer

Volumn 91, Issue 10, 2004, Pages 1769-1774

  Ueno, H ^a   Okusaka, T ^a   Ikeda, M ^a   Takezako, Y ^a   Morizane, C ^a  

^a NATIONAL CANCER CENTER HOSPITAL   (Japan)

Author keywords

Biliary tract cancer; Chemotherapy; Pharmacokinetics; Phase II study; S 1

Indexed keywords

5 CHLORO 2,4 DIHYDROXYPYRIDINE PLUS OXONATE POTASSIUM PLUS TEGAFUR; CISPLATIN; DOCETAXEL; FLUOROPYRIMIDINE DERIVATIVE; FLUOROURACIL; FOLINIC ACID; GEMCITABINE; IRINOTECAN; MITOMYCIN C; PACLITAXEL;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ANOREXIA; ARTICLE; BILE DUCT CANCER; BILIARY TRACT CANCER; BLOOD TOXICITY; CANCER CHEMOTHERAPY; CANCER RADIOTHERAPY; CLINICAL TRIAL; DIARRHEA; DRUG CROSS REACTIVITY; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; FEVER; GALLBLADDER TUMOR; HISTOPATHOLOGY; HISTORY OF MEDICINE; HUMAN; LEUKOPENIA; MALE; NAUSEA; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PIGMENT DISORDER; PRIORITY JOURNAL; RASH; SIDE EFFECT; STOMATITIS; SURVIVAL; THROMBOCYTOPENIA; VATER PAPILLA; VOMITING;

ADMINISTRATION, ORAL; ADULT; AGED; BILIARY TRACT NEOPLASMS; DRUG ADMINISTRATION SCHEDULE; DRUG COMBINATIONS; FEMALE; HUMANS; MALE; MIDDLE AGED; OXONIC ACID; PYRIDINES; TEGAFUR; TREATMENT OUTCOME;

EID: 10844293439     PISSN: 00070920     EISSN: None     Source Type: Journal    
DOI: 10.1038/sj.bjc.6602208     Document Type: Article

References (40)

1. Chollet P, Schoffski P, Weigang-Kohler K, Schellens JH, Cure H, Pavlidis N, Grunwald V, De Boer R, Wanders J, Fumoleau P (2003) Phase II trial with S-1 in chemotherapy-naive patients with gastric cancer. A trial performed by the EORTC Early Clinical Studies Group (ECSG). Eur J Cancer 39: 1264-1270
2. Cohen SJ, Leichman CG, Yeslow G, Beard M, Proefrock A, Roedig B, Damle B, Letrent SP, DeCillis AP, Meropol NJ (2002) Phase I and pharmacokinetic study of once daily oral administration of S-1 in patients with advanced cancer. Clin Cancer Res 8: 2116-2122
3. Comets E, Ikeda K, Hoff P, Fumoleau P, Wanders J, Tanigawara Y (2003) Comparison of the pharmacokinetics of S-1, an oral anticancer agent, in Western and Japanese patients. J Pharmacokinet Pharmacodyn 30: 257-283
4. Ducreux M, Rougier P, Fandi A, Clavero-Fabri MC, Villing AL, Fassone F, Fandi L, Zarba J, Armand JP (1998) Effective treatment of advanced biliary tract carcinoma using 5-fluorouracil continuous infusion with cisplatin. Ann Oncol 9: 653-656
5. Gallardo JO, Rubio B, Fodor M, Orlandi L, Yanez M, Gamargo C, Ahumada M (2001) A phase II study of gemcitabine in gallbladder carcinoma. Ann Oncol 12: 1403-1406
6. Gebbia V, Giuliani F, Maiello E, Colucci G, Verderame F, Borsellino N, Mauceri G, Caruso M, Tirrito ML, Valdesi M (2001) Treatment of inoperable and/or metastatic biliary tree carcinomas with single-agent gemcitabine or in combination with levofolinic acid and infusional fluorouracil: results of a multicenter phase II study. J Clin Oncol 19: 4089-4091
7. Hejna M, Pruckmayer M, Raderer M (1998) The role of chemotherapy and radiation in the management of biliary cancer: a review of the literature. Eur J Cancer 34: 977-986
8. Hirata K, Horikoshi N, Aiba K, Okazaki M, Denno R, Sasaki K, Nakano Y, Ishizuka H, Yamada Y, Uno S, Taguchi T, Shirasaka T (1999) Pharmacokinetic study of S-1, a novel oral fluorouracil antitumor drug. Clin Cancer Res 5: 2000-2005
9. Inuyama Y, Kida A, Tsukuda M, Kohno N, Satake B (2001) Late phase II study of S-1 in patients with advanced head and neck cancer. Can To Kagaku Ryoho 28: 1381-1390
10. Japan Society for Cancer Therapy (1993) Criteria for the evaluation of the clinical effects of solid cancer chemotherapy. J Jpn Soc Cancer Ther 28: 101-130
11. Jones Jr DV, Lozano R, Hoque A, Markowitz A, Patt YZ (1996) Phase II study of paclitaxel therapy for unresectable biliary tree carcinomas. J Clin Oncol 14: 2306-2310
12. Kawahara M, Furuse K, Segawa Y, Yoshimori K, Matsui K, Kudoh S, Hasegawa K, Niitani H (2001) Phase II study of S-1, a novel oral fluorouracil, in advanced non-small-cell lung cancer. Br J Cancer 85: 939-943
13. Koizumi W, Kurihara M, Nakano S, Hasegawa K (2000) Phase II study of S-1, a novel oral derivative of 5-fluorouracil, in advanced gastric cancer. For the S-1 Cooperative Gastric Cancer Study Group. Oncology 58: 191-197
14. Kubicka S, Rudolph KL, Tietze MK, Lorenz M, Manns M (2001) Phase II study of systemic gemcitabine chemotherapy for advanced unresectable hepatobiliary carcinomas. Hepatogastroenterology 48: 783-789
15. Matsushima E, Yoshida K, Kitamura R (1997) Determination of S-1 (combined drug of tegafur, 5-chloro-2,4-dihydroxypyridine and potassium oxonate) and 5-fluorouracil in human plasma and urine using high-performance liquid chromatography and gas chromatography-negative ion chemical ionization mass spectrometry. J Chromatogr B Biomed Sci Appl 691: 95-104
16. Mezger J, Sauerbruch T, Ko Y, Wolter H, Funk C, Glasmacher A (1998) Phase II study of gemcitabine in gallbladder and biliary tract carcinomas. Onkologie 21: 232-234
17. Ohtsu A, Baba H, Sakata Y, Mitachi Y, Horikoshi N, Sugimachi K, Taguchi T (2000) Phase II study of S-1, a novel oral fluorophyrimidine derivative, in patients with metastatic colorectal carcinoma. S-1 Cooperative Colorectal Carcinoma Study Group. Br J Cancer 83: 141-145
18. Ohtsu A, Boku N, Nagashima F, Koizumi W, Tanabe S, Saigenji K, Muro K, Matsumura Y, Shirao K (2001) A phase I/II study of S-1 plus cisplatin (CDDP) in patients (pts) with advanced gastric cancer (AGC). Proc Am Soc Clin Oncol 20: 656
19. Okada S, Ishii H, Nose H, Yoshimori M, Okusaka T, Aoki K, Iwasaki M, Furuse J, Yoshino M (1994) A phase II study of cisplatin in patients with biliary tract carcinoma. Oncology 51: 515-517
20. Okada S, Okusaka T, Ueno H, Ikeda M, Kuriyama H, Saisho T, Morizane C (2002) A phase II and pharmacokinetic trial of S-1 in patients with advanced pancreatic cancer (APC). Proc Am Soc Clin Oncol 22: 171a
21. Okusaka T (2002) Chemotherapy for biliary tract cancer in Japan. Semin Oncol 29: 51-53
22. Papakostas P, Kouroussis C, Androulakis N, Samelis G, Aravantinos G, Kalbakis K, Sarra E, Souglakos J, Kakolyris S, Georgoulias V (2001) First-line chemotherapy with docetaxel for unresectable or metastatic carcinoma of the biliary tract. A multicentre phase II study. Eur J Cancer 37: 1833-1838
23. Pazdur R, Royce ME, Rodriguez GI, Rinaldi DA, Patt YZ, Hoff PM, Burris HA (1999) Phase II trial of docetaxel for cholangiocarcinoma. Am J Clin Oncol 22: 78-81
24. Penz M, Kornek GV, Raderer M, Ulrich-Pur H, Fiebiger W, Lenauer A, Depisch D, Krauss G, Schneeweiss B, Scheithauer W (2001) Phase II trial of two-weekly gemcitabine in patients with advanced biliary tract cancer. Ann Oncol 12: 183-186
25. Polyzos A, Nikou G, Giannopoulos A, Toskas A, Kalahanis N, Papargyriou J, Michail P, Papachristodoulou A (1996) Chemotherapy of biliary tract cancer with mitomycin-C and 5-fluorouracil biologically modulated by folinic acid. A phase II study. Ann Oncol 7: 644-645
26. Raderer M, Hejna MH, Valencak J B, Kornek GV, Weinlander GS, Bareck E, Lenauer J, Brodowicz T, Lang F, Scheithauer W (1999) Two consecutive phase II studies of 5-fluorouracil/leucovorin/mitomycin C and of gemcitabine in patients with advanced biliary cancer. Oncology 56: 177-180
27. Sakata Y, Ohtsu A, Horikoshi N, Sugimachi K, Mitachi Y, Taguchi T (1998) Late phase II study of novel oral fluoropyrimidine anticancer drug S-1 (1 M tegafur - 0.4 M gimestat - 1 M otastat potassium) in advanced gastric cancer patients. Eur J Cancer 34: 1715-1720
28. Sanz-Altamira PM, O'Reilly E, Stuart KE, Raeburn L, Steger C, Kemeny NE, Saltz LB (2001) A phase II trial of irinotecan (CPT-11) for unresectable biliary tree carcinoma. Ann Oncol 12: 501-504
29. Shirasaka T, Nakano K, Takechi T, Satake H, Uchida J, Fujioka A, Saito H, Okabe H, Oyama K, Takeda S, Unemi N, Fukushima M (1996b) Antitumor activity of 1 M tegafur - 0.4 M 5-chloro-2,4-dihydroxypyridine - 1 M potassium oxonate (S-1) against human colon carcinoma orthotopically implanted into nude rats. Cancer Res 56: 2602-2606
30. Shirasaka T, Shimamoto Y, Fukushima M (1993) Inhibition by oxonic acid of gastrointestinal toxicity of 5-fluorouracil without loss of its antitumor activity in rats. Cancer Res 53: 4004-4009
31. Shirasaka T, Shimamato Y, Ohshimo H, Yamaguchi M, Kato T, Yonekura K, Fukushima M (1996a) Development of a novel form of an oral 5-fluorouracil derivative (S-1) directed to the potentiation of the tumor selective cytotoxicity of 5-fluorouracil by two biochemical modulators. Anticancer Drugs 7: 548-557
32. Taal BG, Audisio RA, Bleiberg H, Blijham GH, Neijt JP, Veenhof CH, Duez N, Sahmoud T (1993) Phase II trial of mitomycin C (MMC) in advanced gallbladder and biliary tree carcinoma. An EORTC Gastrointestinal Tract Cancer Cooperative Group Study. Ann Oncol 4: 607-609
33. Taïeb J, Mitry E, Boige V, Artru P, Ezenfis J, Lecomte T, Clavero-Fabri MC, Vaillant JN, Rougier P, Ducreux M (2002) Optimization of 5-fluorouracil (5-FU)/cisplatin combination chemotherapy with a new schedule of leucovorin, 5-FU and cisplatin (LV5FU2-P regimen) in patients with biliary tract carcinoma. Ann Oncol 13: 1192-1196
34. Takada T, Kato H, Matsushiro T, Nimura Y, Nagakawa T, Nakayama T (1994) Comparison of 5-fluorouracil, doxorubicin and mitomycin C with 5-fluorouracil alone in the treatment of pancreatic-biliary carcinomas. Oncology 51: 396-400
35. Tatsumi K, Fukushima M, Shirasaka T, Fujii S (1987) Inhibitory effects of pyrimidine, barbituric acid and pyridine derivatives on 5-fluorouracil degradation in rat liver extracts. Jpn J Cancer Res 78: 748-755
36. Tsavaris N, Kosmas C, Gouveris P, Gennatas K, Polyzos A, Mouratidou D, Tsipras H, Margaris H, Papastratis G, Tzima E, Papadoniou N, Karatzas G, Papalambros E (2004) Weekly gemcitabine for the treatment of biliary tract and gallbladder cancer. Invest New Drugs 22: 193-198
37. Van den Brande J, Schoffski P, Schellens JH, Roth AD, Duffaud F, Weigang-Kohler K, Reinke F, Wanders J, de Boer RF, Vermorken JB, Fumoleau P (2003) EORTC Early Clinical Studies Group early phase II trial of S-1 in patients with advanced or metastatic colorectal cancer. Br J Cancer 88: 648-653
38. van Groeningen CJ, Peters GJ, Schornagel JH, Gall H, Noordhuis P, de Vries MJ, Turner SL, Swart MS, Pinedo HM, Hanauske AR, Giaccone G (2000) Phase I clinical and pharmacokinetic study of oral S-1 in patients with advanced solid tumors. J Clin Oncol 18: 2772-2779
39. van Riel JM, van Groeningen CJ, Pinedo HM, Giaccone G (1999) Current chemotherapeutic possibilities in pancreaticobiliary cancer. Ann Oncol 10: 157-161
40. Yee K, Sheppard BC, Domreis J, Blanke CD (2002) Cancers of the gallbladder and biliary ducts. Oncology (Huntingt) 16: 939-957